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The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMAC injection and PRP injection | Experimental | Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. |
|
| Gel-One® hyaluronate injection | Active Comparator | Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMAC injection | Biological | 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score | Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score. | Change from baseline to 3, 6, and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale | Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain" | Change from baseline to 3, 6, and 12 months post-treatment |
| Patient Reported Outcome Measurement Information System Global Health Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Ruane, DO | Medical Director, McConnell Heart Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McConnell Spine, Sport, and Joint Physicians | Columbus | Ohio | 43214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34434003 | Derived | Ruane JJ, Ross A, Zigmont V, McClure D, Gascon G. A Single-Blinded Randomized Controlled Trial of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee with Active Control. J Stem Cells Regen Med. 2021 Jan 2;17(1):3-17. doi: 10.46582/jsrm.1701002. eCollection 2021. |
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Based on the recruitment details stated, if a participant enrolled but subsequently withdrew or was withdrawn prior to treatment, another participant was enrolled in order to achieve a number of 30 participants who were treated within the study. Per protocol, consented patients could include up to 45 if needed to achieve 30 treated participants.
Number of participants to be treated was capped at 30 participants. However, the approved protocol allowed enrollment of up to 45 participants to achieve a treatment group of 30 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | BMAC Injection and PRP Injection | Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician. PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician. |
| FG001 | Gel-One® Hyaluronate Injection | Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
| |||||||||||||
| Enrollment to Actual Treatment Complete |
| |||||||||||||
| Follow-up Visits |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMAC Injection and PRP Injection | Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician. PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Injury and Osteoarthritis Outcome Score | Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score. | One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 3, 6, and 12 months post-treatment |
|
Adverse events were collected from the time of informed consent/enrollment through approximately 12 months following each participant's treatment date or until participant withdrawal, whichever occurred first.
Included in this report are any adverse events considered unexpected and therefore not listed on the research protocol and informed consent documents as common or likely, less common, or rare risks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMAC Injection and PRP Injection | Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician. PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph J Ruane, DO | OhioHealth | 614-566-3810 | joseph.ruane@ohiohealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2017 | Aug 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| PRP injection | Biological | 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician. |
|
| Gel-One® hyaluronate injection | Device | Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. |
|
The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value. |
| Change from baseline to 3, 6, and 12 months post-treatment |
| NOT COMPLETED |
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| 6 Month Follow-up |
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| 12 Month Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Gel-One® Hyaluronate Injection | Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Previous surgery on target knee knee | Count of Participants | Participants |
|
| Previous injection on target knee | Count of Participants | Participants |
|
| Previous physical therapy on target knee | Count of Participants | Participants |
|
| Onset/course of target knee | Count of Participants | Participants |
|
| Kellgren-Lawrence grade (n, %) | PI assigned grade using criteria from source on p.42: Schiphof D, Boers M, Bierma-Zeinstra SMA. Differences in descriptions of kellgren and lawrence grades of knee osteoarthritis. Annals of the rheumatic diseases. 2008;67(7):1034-1034
| Count of Participants | Participants |
|
| KOOS Pain | The Knee injury and Osteoarthritis Outcome Score consists of 5 subscales (i.e., pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life) developed to assess change over time in those with primary OA or knee injuries resulting in post-traumatic OA (Roos & Lohmander, 2003). A change in 10 points is considered clinically important (Roos & Lohmander, 2003). Scores are reported on a scale of 0-100 with 100 representing the best possible score. | Mean | Standard Deviation | units on a scale |
|
| KOOS Symptoms | The Knee injury and Osteoarthritis Outcome Score consists of 5 subscales (i.e., pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life) developed to assess change over time in those with primary OA or knee injuries resulting in post-traumatic OA (Roos & Lohmander, 2003). A change in 10 points is considered clinically important (Roos & Lohmander, 2003). Scores are reported on a scale of 0-100 with 100 representing the best possible score. | Mean | Standard Deviation | units on a scale |
|
| KOOS ADLs | The Knee injury and Osteoarthritis Outcome Score consists of 5 subscales (i.e., pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life) developed to assess change over time in those with primary OA or knee injuries resulting in post-traumatic OA (Roos & Lohmander, 2003). A change in 10 points is considered clinically important (Roos & Lohmander, 2003). Scores are reported on a scale of 0-100 with 100 representing the best possible score. | Mean | Standard Deviation | units on a scale |
|
| KOOS Sport & Recreation | The Knee injury and Osteoarthritis Outcome Score consists of 5 subscales (i.e., pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life) developed to assess change over time in those with primary OA or knee injuries resulting in post-traumatic OA (Roos & Lohmander, 2003). A change in 10 points is considered clinically important (Roos & Lohmander, 2003). Scores are reported on a scale of 0-100 with 100 representing the best possible score. | Mean | Standard Deviation | units on a scale |
|
| KOOS Quality of Life | The Knee injury and Osteoarthritis Outcome Score consists of 5 subscales (i.e., pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life) developed to assess change over time in those with primary OA or knee injuries resulting in post-traumatic OA (Roos & Lohmander, 2003). A change in 10 points is considered clinically important (Roos & Lohmander, 2003). Scores are reported on a scale of 0-100 with 100 representing the best possible score. | Mean | Standard Deviation | units on a scale |
|
| NPRS | The 11-point Numeric Pain Rating Scale (NPRS) is commonly used to assess the level and change of patient reported pain over time. Pain is rated from 0 to 10 with zero representing 'no pain' and 10 representing 'worst imaginable pain' (Farrer, Young, LaMoreaux, Werth, & Poole, 2001). A 2-point or 30-33% reduction has been established as a clinically important difference in populations with chronic musculoskeletal pain, including knee OA (Farrer, Young, LaMoreaux, Werth, & Poole, 2001; Salaffi, Stancati, Silvestri, Ciapetti, & Grassi, 2004). | Mean | Standard Deviation | units on a scale |
|
| PROMIS Global Health Physical Score | The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). | Mean | Standard Deviation | units on a scale |
|
| PROMIS Global Health Mental Score | The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Gel-One® Hyaluronate Injection | Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. |
|
|
| Secondary | Numeric Pain Rating Scale | Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain" | One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 3, 6, and 12 months post-treatment |
|
|
|
| Secondary | Patient Reported Outcome Measurement Information System Global Health Scores | The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value. | One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 3, 6, and 12 months post-treatment |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Gel-One® Hyaluronate Injection | Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D012216 |
| Rheumatic Diseases |
| NPRS (6 months) |
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| NPRS (12 months) |
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| PROMIS Mental Health (3 months) |
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| PROMIS Physical Health (6 months) |
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| PROMIS Mental Health (6 months) |
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| PROMIS Physical Health (12 months) |
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| PROMIS Mental Health (12 months) |
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